Regent has the following investments of significance:
The Diabetic Boot Company Limited
The Group holds 133,231 shares (or 22%) in The Diabetic Boot Company Limited. Diabetic Boot is a private single product medical device company based near Oxford, in the UK. Diabetic Boot is focussed on the treatment of diabetic foot ulcers (“DFUs”), which are a comorbidity of diabetes mellitus. The treatment of DFUs represents a significant commercial opportunity with the current standard of care and alternative therapies lacking efficacy.
Diabetic Boot’s lead product is Pulseboot which combines intermittent plantar compression with the current standard of care for the treatment of DFUs called offloading. Intermittent plantar compression as a mechanism of action has been shown in independent clinical studies to produce statistically significant improvements over placebo in wound closure.
In 2014, the prevalence of diabetes in the UK was 5.38 per cent of the total population. It is estimated that approximately 2.5% of diabetics have DFUs at any given time These prevalence rates led the NHS in England to spend approximately GBP 1 in every GBP 150 on the treatment of DFUs and associated lower limb amputation. Similar rates of diabetes and ulceration are observed in other markets. The prevalence of diabetes in China is notably above that of the UK standing at 9.32% in 2014. In absolute number this represents the largest diabetic population by country at approximately 130 million people.
Pulseboot is approved for sale in Europe having been granted a CE mark in December 2013 as a Class IIa medical device. Diabetic Boot submitted an FDA 510(k) application for Pulseboot in March 2015 with approval expected to be granted by the end of the third quarter of 2015.
Diabetic Boot has distribution agreements in place in a number of geographies including Australia, Canada, New Zealand, Germany, Austria, Switzerland and Saudi Arabia. Diabetic Boot hopes to expand this list and the Company believes it is well placed to assist in particular in its local Asia Pacific region.
More information is available at DiabeticBoot’s website at www.pulse-flow.co.uk.